Data from the phase 3 LIMMitless show patients received long-term benefit from the biologic, regardless of baseline demographic or disease status.
Risankizumab was associated with 90% psoriasis skin clearance in more than 8 in every 10 treated patients after 5 years, according to new data.
In data from the ongoing phase 3, open-label extension LIMMitless Trial, presented at the 2022 Fall Clinical Dermatology Meeting this week, a team of AbbVie-supported investigators observed consistent long-term efficacy benefits for patients with psoriasis treated with the IL-23 inhibitor—regardless of baseline demographics and disease characteristics.
The findings support an interpretation of risankizumab as a durable and reliable therapy for moderate-to-severe psoriasis, a common skin condition with heterogeneous affect and progression in patients of all ages.
Led by Bruce Strober, MD, PhD, clinical professor of dermatology at Yale University School of Medicine, investigators conducted an interim analysis of the ongoing, open-label extension trial for risankizumab, in which the agent’s efficacy over 4.5 years of continuous care is being assessed in patients with moderate-to-severe disease.
The previous UltlMMa-1 trial showed risankizumab’s superior efficacy to placebo over 16 weeks; the UltlMMa-2 showed its superiority versus competing biologic ustekinuamb at weeks 16 and 52. Investigators now sought 256-week outcomes.
“Multiple biologic agents are available to treat psoriasis; however, their efficacy may decrease over time in some patient subgroups,” investigators wrote.
The 256-week interim analysis included patients recruited from the UltilMMa trials who were randomized to 150 mg risankizumab. Strober and colleagues sought a primary outcome of treatment efficacy per proportion of patients achieving ≥90% or 100% improvement of disease, defined by Psoriasis Area Severity Index scores of 90 or 100 (PASI 90, PASI 100). Patients were assessed once every 12 weeks.
Investigators additionally evaluated patient treatment benefit based on baseline demographics including age, sex, body mass index (BMI), and weight, as well as disease characteristics including psoriatic arthritis (PsA) status and baseline PASI score.
The interim analysis included 525 patients receiving risankizumab. Two-thirds (69.3%) of patients were male; mean age was 47.7 years old; mean BMI was 30.4; and mean baseline PASI was 20.4.
The team observed 85.1% of all treated patients in LIMMitless achieved PASI 90 at week 256; the proportion of those who achieved it based on baseline demographic or clinical status subgroups did not significantly differ from one another. PASI 90 proportions were similar for patients of each of the following baseline descriptions:
“Multivariate logistic regression analyses demonstrated consistent efficacy after accounting for multiple covariates commonly associated with reduced efficacy responses to treatment,” the team noted.
Investigators concluded that risankizumab was associated with durable efficacy response after 5 years of treatment in patients with moderate-to-severe psoriasis, regardless of weight, age, gender or psoriasis status at baseline.
The study, “Efficacy of Risankizumab for Moderate-to-Severe Plaque Psoriasis Through 256 Weeks: Subgroup Analysis by Baseline Demographics and Disease Characteristics From the LIMMitless Trial,” was presented at Fall Clinical 2022.